Medical device licence · 96622 · Class 3
SPIRATION VALVE SYSTEM (SVS)
Yes: licensed in Canada
Licence status Issued (active); first licensed March 2, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96622
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 2, 2016
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SVS AIRWAY SIZING KIT
- SVS DEPLOYMENT CATHETER AND LOADER
- SVS VALVE IN CARTRIDGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.